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프린트
전체 255건, 현재 페이지 19/26
GPKOL
임상 R & D기획
미국
Biochemistry, Medical Biochemistry, Microbiology, Chemistry
임상 PM 인허가
프랑스
Project Management As Global Project Director led teams to develop and obtain marketing approval in parallel in Europe and America involves trouble shooting, contingency planning and coordination of and communication with team members, investígalo rs, reguiatory authorities and sponsor company. Knowledge in all aspects of Drug Development. Reguiatory Researched fast track and Orphan drug strategies and applied for and received special designations from FDA and EMEA under which the drugs were approved, resulting in shorter timelines and reduced fees (saving money and time). Developed good working relationships with reguiatory authorities. Have filed 505 (b)(l), 505 (b)(2)applications withsuccess. Clínica! Triáis Determine the best strategy for conduct of clinical studies wíth a balance between speed and costof studies in different countries. Also the regulatory differencés in obtaining clinical trial a p pro vals are.taken into consideraron. Havedeveloped a large network of Investigators, especially in oncology.
R & D기획
Drug Delivery/Innovative Formulation Technology Experiences Sustained and Long Acting Release System: Biodegradable microparticle/nanoparticle, injectable in situ forming bioabsorbable hydrogel depot, and polymeric multilayer implant system Targeted Drug Delivery: Ligand conjugated nanoparticles for cancer therapeutics and targeted liposome for siRNA delivery Half-Life Extension Technology: Polymer-drug conjugate, site-specific PEGylation strategies for maximizing efficacy of biopharmaceuticals Transmucosal Delivery: Buccal, sublingual, and intranasal delivery Transdermal Delivery: Drug-in-adhesive matrix formulation
R & D기획 임상
R&D기획 1. drug discovery and development/ lead optimization/pharmacology/PK&PD/biomarkers and diagnostics/toxicology/pharmaceutics(CMC)/clinical development and regulatory requirements for small molecule and therapeutic antibody 2.Expertise in research strategic planning and mangement of projects 3. strong experience in building and constructing business plan and managing start-up biotech company(co-founder of PharmAbcine) 4. strong industry experiences in global biotech and pharmaceutical companies including Chiron (currently Novartis), AstraWeneca, Genentech and Exelixis 임상 1)IND, clinical protocol, investigator brochure 작성 2)leading clinical management/operation 3.biomarkers and diagnostic strategy in clinical trials
R & D기획 PM
R&D Drug metabolism and pharmacokinetics (DMPK) Lead optimization of New Chemical Entities (small molecule, peptide and SiRNA) compartmental/non-compartmental PK, TK, PK-PD and PBPK (Phoenix WinNonlin/GastroPlus/ Matlab Simbiology/SimCYP) Project Management Lead a cross-functional team of biotransformation, ADME, project representatives to conceive and execute development strategies to address short- and long-term issues related to ADMET and PK properties in Neuroscience, Oncology, Antiviral and Ophthalmologic drug development
독성학 신약개발에 관련한 R&D기획, 전임상, 독성학 실험과 Regulatory submission
Optimizing commercial strategies for new medical products and services, including mapping out optimal development pathways for novel medical products to help improve the chances of developmental success and commercial success in the market Cost and clinical effectiveness studies for healthcare organizations 1.Commercialization Strategy Evaluating and recommending the strategic approach to optimize commercial value of new medical products and services 2.Cost Effectiveness/Value Analysis Quantifying the cost effectiveness of new medical products and services (relative to their clinical safety and efficacy) 3.Pricing, Reimbursement and Market Access Developing pricing, reimbursement and market access strategies for new medical products and services Helping companies develop more solutions-oriented approaches to helping sell their healthcare products and services, which includes incorporating services and health IT into more comprehensive solutions for the marketplace Evolution of global markets for healthcare products and services, especially in Asia
Clinincal pharmacology studies (including Bioequivalence/Bioavailability study Relative Bioavailability study, First time in Man study, Drug Interaction study Drug Probe cocktail study, Special Population study Proof of Concept study, Phase II and Phase III studies Population PK study): study design, protocol writing, data analysis result interpretation and report writing for regulatory submission.
대한민국
- R&D기획 Cancer biology, drug discovery/development, R&D 기획 - Project Management 프로젝트 전략 수립, 라이센싱
임상(관절염 및 자가 면역 질환) R&D(관절염 동물모델)
